Hazard and hazardous situation
ISO 14971 defines the terms “hazard” and “hazardous situation.” Nevertheless, medical device manufacturers often find it difficult to assign concrete cases to either of the two categories. This article provides help.
Instructions for use for medical devices and IVDs in the EU
Poor instructions for use are a common cause of use errors that can result in harm to patients and users. Furthermore, instructions for use for medical devices and IVDs are subject to strict regulatory requirements. The MDR, the IVDR, the FDA and numerous standards establish specific requirements for the instructions for use. This article will…
DetailsElectronic instructions for use for medical devices (EU law)
EU Regulation 2017/745 (MDR) establishes the general requirements for instructions for use (IFU). Whether they can also be provided in electronic form (eIFU) is regulated by Implementing Regulation (EU) 2021/2226. We have summarized the requirements for electronic instructions for use for you.
DetailsISO 15223-1: Medical symbols and labels
The standard ISO 15223-1, regulates the symbols that manufacturers are permitted to/must use for labeling medical devices. In January 2022, the EU Commission harmonized EN ISO 15223-1 as one of relatively few standards under the MDR and added it to the list of harmonized standards. This alone makes it clear how relevant labeling has become. …
DetailsUnit testing and IEC 62304
In software development, unit testing refers to the testing of software units. However, there is no common understanding of This article provides clarity.
DetailsIntended purpose and intended use: More consequences than you think!
The correct and precise formulation of the intended purpose of medical devices and in vitro diagnostic medical devices (IVD) is crucial for their successful development and approval. However, even the definitions of terms and the distinction between intended purpose and intended use make it difficult to achieve clarity and precision. This article reveals how to…
Details21 CFR part 11: An over-interpreted law?
In 21 CFR part 11, the FDA establishes its requirements for electronic records and signatures, which also apply to medical device manufacturers. A lot of companies print everything out on paper and then sign it by hand to circumvent the requirements of part 11. Is this really necessary?
DetailsSystems and procedure packs
The European legislation defines systems and procedure packs and distinguishes between different configurations. The regulatory requirements placed on the manufacturer are heavily dependent on these configurations. This article will explain to you what legislators understand by systems and procedure packs, what the most important legal requirements are for manufacturers, and what common mistakes you should avoid.
DetailsElectronic and digital signatures
Electronic and digital signatures should be considered on an equal level to handwritten signatures (“wet ink”). The requirements that need to be fulfilled depend on the extent of the binding force that is to be achieved and so depend on the document that is to be signed. This article explains
DetailsSampling kits from a regulatory perspective
The term “sampling kit” is not defined by the IVDR or any other regulation. Nevertheless, there are (indirect) regulatory requirements that IVD manufacturers and medical laboratories must be aware of and consider. The requirements depend on the particular constellation. This article presents five constellations. It provides clarity and helps to avoid regulatory hassles and minimize…
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